MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE FILTER 19X1-1/2 TW; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305200
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd needle filter 19x1-1/2 tw had foreign matter.The following information was provided by the initial reporter: material # 305200, batch # 2172517.Verbatim: rcc received a complaint via email."black specks on the top of the syringe with the product, after the medication was drawn from the vial" lot# 2172517.New information provided: "specks were observed in both syringe and in needle (bd syringe lot # 3034733, bd needle lot # 2172517".
Additional Manufacturer Narrative
It was reported that black specks were observed on the top of the syringe.To support the investigation, one sample without packaging and three photographs were provided for evaluation by the quality team.A visual inspection confirmed that the plastic shield contained dark-colored specks of embedded degraded resin at the bottom.The photographs corresponded to the sample received, and no additional defects or imperfections were identified.The presence of degraded resin in the component typically occurs during startup or intermittently throughout the injection molding process, when degraded material can break loose and become incorporated into molded parts.A review of the device history record for material number 305200, lot 2172517, revealed no detected quality issues during production that could have contributed to the reported condition.No related quality notifications were identified, and all processes and final inspections were performed in compliance with specification requirements.The sample will be shared with associates for awareness.Based on the investigation and analysis of the returned sample, the customer¿s reported observation has been confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.It was reported that black specks were observed on the needle and hub.To support the investigation, one sample without packaging and three photographs were provided for evaluation by the quality team.A visual inspection confirmed that the plastic shield contained dark-colored specks of embedded degraded resin at the bottom.The photographs corresponded to the sample received, and no additional defects or imperfections were identified.The presence of degraded resin in the component typically occurs during startup or intermittently throughout the injection molding process, when degraded material can break loose and become incorporated into molded parts.A review of the device history record for material number 305200, lot 2172517, revealed no detected quality issues during production that could have contributed to the reported condition.No related quality notifications were identified, and all processes and final inspections were performed in compliance with specification requirements.The sample will be shared with associates for awareness.Based on the investigation and analysis of the returned sample, the customer¿s reported observation has been confirmed.

• Brand Name: BD NEEDLE FILTER 19X1-1/2 TW
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23700957
• Report Number: 1911916-2025-00775
• Device Sequence Number: 18809720
• Product Code: GAA
• UDI-Device Identifier: 00382903052004
• UDI-Public: (01)00382903052004(17)270630(10)2172517
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305200
• Device Lot Number: 2172517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown